NCT03435952 - Pembrolizumab With Intratumoral Injection of Clostridium Novyi-NT | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 10, 2018

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2026

Conditions

Malignant Neoplasm of BreastMalignant Neoplasms of Digestive OrgansMalignant Neoplasms of Eye Brain and Other Parts of Central Nervous SystemMalignant Neoplasms of Female Genital OrgansMalignant Neoplasms of Ill-defined Secondary and Unspecified SitesMalignant Neoplasms of Independent (Primary) Multiple SitesMalignant Neoplasms of Lip Oral Cavity and PharynxMalignant Neoplasms of Male Genital OrgansMalignant Neoplasms of Mesothelial and Soft TissueMalignant Neoplasms of Respiratory and Intrathoracic OrgansMalignant Neoplasms of Thyroid and Other Endocrine GlandsMalignant Neoplasms of Urinary Tract

Interventions

DRUG

Pembrolizumab

200 mg by intravenous infusion starting on Day 0, and continuing every 3 weeks for up to 12 months.

BIOLOGICAL

Clostridium Novyi-NT

"Participants given a single dose of Clostridium Novyi-NT by intratumoral injection on Day 8.~Clostridium Novyi-NT administered starting with Cohort 1 at a dose of 3 x 10\^4 spores followed by dose escalation."

DRUG

Doxycycline

Starting on Day 15, participant takes Doxycycline by mouth 2 times a day for the rest of participant's life to lower the risk of further growth of Clostridium novyi-NT

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston